Casper Parma receives EIR on conclusion of USFDA pre-approval inspection
Suven Pharmaceuticals announces today that the US Food and Drug Administration (USFDA) has issued an EIR for its wholly owned
Subsidiary Casper Parma, a finished dosage drug Manufacturer for human
use.
The pre- approval inspection was conducted during 25 July 22 through 29 July 22.
Pre-Approval Inspections covering of three applications: NDA 016084, ANDA 217020, & ANDA 217030.
The inspection concluded with no observation (FDA-483) issued.
EIR received from US FDA states that the site is recommended for approval of the three NDA & ANDA listed above.
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First Published: Oct 04 2022 | 2:19 PM IST